ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Preemptive Epidural Analgesia in Labor on Cytokine Production

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00361712
Recruitment Status : Completed
First Posted : August 8, 2006
Results First Posted : March 12, 2018
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
sharonorbach, Rabin Medical Center

Brief Summary:

During labor there is an increased production of inflammatory mediators called cytokines. Higher concentration of certain cytokines has been linked to adverse neonatal and maternal outcomes.

Epidural analgesia is commonly performed after the parturient feels labor pain.

We hypothesis that preemptive epidural analgesia (initiated before labor pain begins)can influence the production of cytokines.


Condition or disease Intervention/treatment Phase
Obstetric Pain Procedure: Preemptive epidural analgesia Drug: Standard of care Phase 4

Detailed Description:

The interrelationship between vaginal labor, cytokine production, and epidural analgesia is unknown. Vaginal delivery is thought to induce a maternal inflammatory response. Though epidural analgesia during labor was found to significantly influence peripartum maternal and newborn interleukin concentrations, these studies did not address at what stage epidural analgesia was performed. Preemptive analgesia has been found to be associated with attenuated proinflammatory cytokines, at least in the postoperative period.

Healthy ASA I term parturients (>37 weeks) being accepted into delivery ward and wanting epidural analgesia will be studied.

Parturients will be divided into two groups:

  • Group I- those who have painless contractions awaiting augmentation of labor.
  • Group II- parturients with cervical dilatation and painful labor (VAS >5).

Parturients in Group I will be given epidural analgesia immediately upon arrival in the labor ward before onset of painful contractions (VAS<3). Parturients in Group 2 will be given epidural analgesia as soon as possible.

Epidural analgesia protocol will be identical for both groups: graduated doses of bupivicaine 0.1% 15cc and 100 mcg fentanyl followed by patient controlled analgesia at a concentration of bupivicaine 0.1% and fentanyl 2 mcg/cc delivered at 10cc per hour with possible boluses of 5 cc every ten minutes.

Maternal serum will be drawn before epidural insertion and 18-24 hours after delivery. Placental blood will be drawn after delivery.

These blood sample will be assessed for IL-1Beta, TNF alpha, IL-1ra, IL-2, Il-6, IL-8, IL-10, IL-18.

The patient's chart will be prospectively analyzed for demographic information about parturient and complications and progress of labor.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Preemptive Epidural Analgesia in Labor on Pro and Anti-inflammatory Cytokine Production in a Mother and a Newborn
Study Start Date : July 2006
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Arm Intervention/treatment
Experimental: Preemptive epidural analgesia
Parturients will receive epidural analgesia immediately upon arrival in the labor ward before onset of painful contractions (VAS<3).
Procedure: Preemptive epidural analgesia
Parturients will receive early epidural analgesia before onset of painful contractions as oppose to standard of care in which parturients receive epidural analgesia with onset of painful contractions.
Active Comparator: Standard of care
Parturients with cervical dilatation and painful labor (VAS >5) will receive epidural analgesia as soon as possible
Drug: Standard of care
Epidural analgesia with parturients with cervical dilatation and painful labor (VAS >5)



Primary Outcome Measures :
  1. Maternal Cytokine IL-10 Levels of pg/ml Upon Enrollment [ Time Frame: Right after enrollment ]
    Maternal serum cytokine IL-10 levels of pg/ml measured upon enrollment

  2. Maternal Cytokine of pg/ml IL-10 Levels 24 Hours After Delivery [ Time Frame: 24 hours after delivery ]
    Maternal serum cytokine levels of pg/ml IL-10 as measured 24 hours after delivery

  3. Umbilical Cord Cytokine of pg/ml IL-10 Levels at Birth [ Time Frame: At birth of parturients ]
    Umbilical cord cytokine IL-10 levels pg/ml as measured at delivery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age>18
  2. Singleton pregnancy with no known fetal malformations
  3. Above or equal to 38 weeks of pregnancy

Exclusion Criteria:

  1. Systemic medical illnesses
  2. Chronic medications except for iron and vitamins
  3. Women developing fever > 380C
  4. Women with history of delivery of children with cerebral palsy
  5. History of infertility
  6. Premature contractions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00361712


Locations
Israel
Rabin Medical Center/Beilinson Campus
Petach Tikva, Israel, 49100
Sponsors and Collaborators
Rabin Medical Center
Investigators
Study Director: Sharon Orbach-Zinger, M.D. Department of Anesthesiology, Rabin Medical Center/Beilinson Hospital

Responsible Party: sharonorbach, Dr, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT00361712     History of Changes
Other Study ID Numbers: 003692
First Posted: August 8, 2006    Key Record Dates
Results First Posted: March 12, 2018
Last Update Posted: April 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by sharonorbach, Rabin Medical Center:
Epidural
analgesia
labor
cytokines

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms